1. Gentofte University Hospital
Long-term Cardiac Arrhythmias recorded by an Insertable Loop Recorder in Patients with Depressed Left Ventricular Function after Acute Myocardial Infarction
CARISMA
Cardiac Arrhythmias and RIsk Stratification after Myocardial infArction
PE Bloch Thomsen,MD,PhD
Gentofte University Hospital
Copenhagen, Denmark
geh.regionh.dk

2. CARISMA investigators
European multicenter, prospective, observational study
Principal investigators: H. Huikuri, Finland, PE Bloch Thomsen, Denmark
P. Raatikainen University of Oulu, Finland
R.M. Joergensen University of Copenhagen, Denmark
J. Hartikainen University of Kuopio, Finland
V. Virtanen University of Tampere, Finland
J. Boland Hopital Citadelle, Liège, Belgium
O. Anttonen Paijat-Hame Hospital, Lahti, Finland
L.A.V. Boersma St. Antonius Hospital, Nieuwegein, Netherlands
E.S. Platou University of Oslo, Norway
E. Stoupel Hopital Erasme, Brussels, Belgium
J. Rokkedal, N. Hoest Amtssygehuset Glostrup, Denmark

3. Disclosures Research grant and speaker fee Boston Scientific Guidant
Medtronic BRC
St. Jude Medical
CARISMA was sponsored by
Medtronic Bakken Research Center
Cambridge Heart Inc

4. (HRS, Hot Line Session, Denver, May 10, 2007)
CARISMA – Objective 1
Assess the predictive value of electrophysiologic testing and non-invasive screening tests for life-threatening tachyarrhythmias in patients surviving AMI with EF ≤ 0.40
(HRS, Hot Line Session, Denver, May 10, 2007)

5. CARISMA – Objective 2
Document the incidence and assess the prognostic significance of cardiac arrhythmias obtained from an implantable ECG loop recorder

6. Implantable loop recorder
Weight 1/2 oz, 8 cc. Longevity up to 2 years.
ECG storage 42 min, automatic arrhythmia detection algorithms
Sampling rate 100 Hz

7. Inclusion criteria Exclusion criteria
Patients within 3 to 21 days of AMI
+ CKMB or Troponin elevation
+ Typical chest pain or ECG changes
EF ≤ 40%, 2-D echo ( WMI ≤ 1.3)
Exclusion criteria
Planned CABG/ ICD
NYHA IV
Informed consent not obtained

8. Study design 5869 pts with AMI 3-21 days post-MI 5-21 days post-MI
1393 (24%) EF ≤ 40%
312 pts
informed consent
5-21 days post-MI
ILR implantation
297 pts
2 year post-MI
Quarterly follow-up

9. Patient characteristics Enrollment: 2002-2005
Revascularization
Primary PCI 30%
Thrombolysis 35%
Rx at discharge
ASA 90%
Beta-blockers 96%
ACE / AT II 89%
Statins 82%
Baseline
# of pts 312
Gender (men) 77%
Age (years) 65  11
LVEF 31%  6
AFib permanent 9%
QRS > 120 ms 15%
Diabetes 20%
Prior MI %
Hx of CHF (II-III) 11%

10. Definitions Pre-specified arrhythmia
Sinus bradycardia ≤ 30 bpm, ≥ 8s
Sinus arrest ≥ 5s
AV block (2°, 3°) ≤ 30 bpm, ≥ 8s
Non-sustained VT ≥ 125 bpm, ≥16 beats
Sustained VT ≥ 125 bpm, ≥30s
AFib ≥ 125 bpm

11. Incidence of arrhythmias recorded by the ILR
Mean follow-up 1.9 years
137 pts (46%) documented at least
one of the pre-specified arrhythmias
86% were asymptomatic

12. Bradyarrhythmia: Time to first arrhythmia by ILR
Sinus arrest (>5s) n= 16 (5%)
Sinus brady (>8s) n= 20 (7%)
AV block (>8s) n=29 (10%) •

13. 1 s

14. Tachyarrhythmia: Time to first arrhythmia by ILR
Ventricular Fib. n=8 3%
VT Sust. n=9 3%
VT Non-sust. n=39 13% AFib n=95 32%

16. Conclusion Incidence of arrhythmias
27% had new onset atrial fibrillation
17% had high degree AV block or
sinus bradyarrhythmia
17% had non-sust VT or VT/VF

17. Univariate analysis Predictors of cardiac death N = 25 (9%)HR
p-value
AV block < 30 bpm
7.0
0.0004
Sinus brady < 30 bpm
5.8
0.004
Non sustained VT
3.4
0.025

18. Multivariate analysis
High-degree AV block was the only
independent predictor of cardiac death
HR 4.8 [ ] p < 0.001
Pre-specified arrhythmias were included as time dependent covariates in a multivariate Cox model.

19. Summary
CARISMA is the first study to report on long term arrhythmias and prognostics by an
implantable loop recorder
in patients surviving an AMI with
reduced left ventricular function

20. was the only independent predictor of
Conclusion
High-degree AV block
was the only independent predictor of
cardiac death

21. Future directions
The insertable ECG loop recorder is a diagnostic tool that should be considered to guide medical and device therapy in patients surviving myocardial infarction